Thera plus Antifungal Tolnaftate

Thera plus Antifungal Tolnaftate is an FDA-registered drug product whose active ingredient is TOLNAFTATE. It is labelled by FOURSTAR GROUP USA, INC. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 80684-040, application M005, label effective 20231026. It is one of 53 FDA drug label records sharing the active ingredient TOLNAFTATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TOLNAFTATE are most often described in connection with: athlete foot, proven clinically, tinea pedis, corporis helps, effective relief, itching burning. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching , burning , and cracking

Directions wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete’s foot: pay special attention to spaces between the toes, wear well-ftting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks ; if condition persists longer, ask a doctor. to prevent athlete’s foot, apply once or twice daily (morning and/or night). this product is not effective on the scalp or nails.

Warnings For external use only. Do not use on children under 2 years of age except under the advice and supervision of a doctor. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

FDA lists 53 drug label records with TOLNAFTATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Thera plus Antifungal Tolnaftate used for?
Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching , burning , and cracking

Who makes Thera plus Antifungal Tolnaftate?
FOURSTAR GROUP USA, INC. is the labeler of record for Thera plus Antifungal Tolnaftate. 53 FDA label records share the active ingredient TOLNAFTATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Thera plus Antifungal Tolnaftate come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Thera plus Antifungal Tolnaftate prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TOLNAFTATE?
Yes. 53 FDA drug label records list TOLNAFTATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Thera plus Antifungal Tolnaftate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.